Levemir · 4.1 Therapeutic indications · 1

HOS-093718 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Adverse reactions observed in patients using Levemir are mainly due to the pharmacologic effect of insulin. The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%. The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions. From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir. Injection site reactions are seen more frequently during treatment with Levemir than with human insulin products. These reactions include pain, redness, hives, inflammation, bruising, swelling and itching at the injection site. Most of the injection site reactions are minor and of a transitory nature, i.e. they normally disappear during continued treatment in a few days to a few weeks. At the beginning of the insulin treatment, refraction anomalies and oedema may occur; these reactions are usually of transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. Tabulated list of adverse reactions Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 7 Immune system disorders Uncommon – Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions* Very rare – Anaphylactic reactions* Metabolism and nutrition Very common – Hypoglycaemia* disorders Nervous system disorders Rare – Peripheral neuropathy (painful neuropathy) Eye disorders Uncommon – Refraction disorders Uncommon – Diabetic retinopathy Skin and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093714 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

HOS-093713 · has-indication-information · PDF-Seite 2

Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

HOS-093716 · has-interaction-information · PDF-Seite 6

A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patient’s insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides. The following substances may increase the patient’s insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

HOS-093717 · has-pregnancy-information · PDF-Seite 6

Pregnancy The use of Levemir in pregnant women with diabetes has been investigated in a clinical trial and in a prospective non-interventional post-authorisation safety study (see section 5.1). Post-marketing data in pregnant women using Levemir, with more than 4,500 pregnancy outcomes do not indicate any increased risk of malformative or feto/neonatal toxicity. Treatment with Levemir can be considered during pregnancy, if clinically needed. In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester. After 6 delivery, insulin requirements normally return rapidly to pre-pregnancy values. Breast-feeding It is unknown whether insulin detemir is excreted in human milk. No metabolic effects of ingested insulin detemir on the breast-fed newborn/infant are anticipated since insulin detemir, as a peptide, is digested into amino acids in the human gastrointestinal tract. Breast-feeding women may require adjustments in insulin dose and diet. Fertility Animal studies do not indicate harmful effects with respect to fertility.

HOS-093715 · has-warning-information · PDF-Seite 4

4 Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected, Levemir must not be injected. After stabilisation of the patient’s blood glucose, adjustment of the dose should be considered (see sections 4.8 and 4.9). Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in insulin dose. When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin. Transfer from other insulin medicinal products Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose. Patients transferred to Levemir from

Auszug; vollständigen Abschnitt im Original lesen.